Kornimate/medical-research-clean huggingface dataset:
serum and corporal irisin level and its correlation with erectile function in diabetic obese patients

Conditions: Serum and Corporal Irisin in Diabetic Patients With Erectile Dysfunction

Summary: obese and diabetic men constitute a huge fraction of ed patients. there is established relation between both obesity ,diabetes and ed through multiple neuroendocrine and vascular players . a limited number of serum biomarkers are available for ed with diabetic patients. these are biomarkers often used for endothelial dysfunction, inflammation and oxidative stress. serum e-selectin, endothelial progenitor cell (epc), endothelial micro particle (emp), tumour necrosis factor / interleukin-10 (tnf-a / il-10), nitric oxide (no), mda (malondialdehyde) and lipoprotein (a) are the most used biomarkers in this population.

obese and diabetic men constitute a huge fraction of ed patients. there is established relation between both obesity ,diabetes and ed through multiple neuroendocrine and vascular players . a limited number of serum biomarkers are available for ed with diabetic patients. these are biomarkers often used for endothelial dysfunction, inflammation and oxidative stress. serum e-selectin, endothelial progenitor cell (epc), endothelial micro particle (emp), tumour necrosis factor / interleukin-10 (tnf-a / il-10), nitric oxide (no), mda (malondialdehyde) and lipoprotein (a) are the most used biomarkers in this population. irisin is a novel skeletal muscle- and adipose tissue-secreted peptide. it is conventionally regarded as an adipomyokine and is a cleaved fragment of fibronectin type iii domain containing protein 5 (fndc5). it is involved in the browning of white adipose tissue, glucose tolerance, and reversing of metabolic disruptions. irisin exerts a direct vascular protective effect on endothelial function:- the mechanism for this protective effect of irisin appeared to be related amp activated protein kinase and endothelial no synthase (ampk-enos) signaling pathway activation.irisin enhanced no production and phosphorylation of ampk, akt, and enos in endothelial cells. according to a recently published study, the use of exogenous irisin is thought to alleviate endothelial dysfunction in t2dm by reducing oxidative / nitrative stresses. therefore, it can be used in the future to eliminate the vascular complications of diabetes.although the relationship between t2dm, endothelial dysfunction and irisin has been demonstrated in many previous studies.

Eligibility criteria:
inclusion criteria: * age of patients 30-50 years old . * patients with type ll diabetes mellitus . * patients on oral hypoglycemic medications . * non responders pdei-5 ed patients exclusion criteria: * age of patients above 60 years old . * patients with type l diabetes mellitus on insulin . * patients with hypogonadism .
ghrelin effect on beta cell function in health and disease

Conditions: Diabetes

Summary: to determine the role of nutrient status on ghrelin regulation of insulin secretion. we hypothesize that ghrelin and glucagon-like peptide-1 (glp-1)(both are hormones made in the gut,) have differential effects on β-cell function in the fed state. we will compare insulin secretion and glucose turnover during meal ingestion using a dual glucose tracer and mixed meal protocol in subjects receiving ghrelin or saline. we will also determine the role of ghrelin-stimulated glp-1 levels in this process using the glp-1 receptor (glp-1r) antagonist exendin(9-39) (ex-9).

we plan to study 20 healthy subjects on 4 occasions where they will receive ghrelin, ghrelin+ex-9, ex-9 or saline infusion after an overnight fast in a randomized order; ex-9 will be used to block glp-1 action. a 240-minute meal tolerance test (mtt) using a dual glucose tracer method will serve as the foundation of each study visit. one tracer, \[6,6-2h2\]glucose will be infused intravenously before and during the test meal to quantify fasting endogenous glucose production (egp), and glucose disappearance during the meal. a second tracer, \[u-13c\]glucose, will be included in the meal to trace the appearance of oral glucose. the systemic appearance rates of both ingested tracer and total (i.e., ingested and endogenously produced) glucose will be calculated. using this protocol, we will be able to evaluate a) insulin secretion in response to mixed-meal ingestion, b) glucose appearance and glucose disappearance during meal ingestion, c) the ghrelin effect on these parameters without glp-1, and d) the effect of glp-1 in the response based on the effects with and without ex-9. this dual-tracer method has been used to assess the ability of an individual to dispose of an oral glucose load, and accurately fractionates the appearance of ingested glucose in plasma (ra meal), egp, and peripheral glucose disposal (rd) in this setting 41-42. the \[6,6-2h2\]glucose and \[u-13c\]glucose are stable-isotope tracers and are different from radioactive-isotope tracers in that they do not emit radiation. all procedures will be performed at the ctrc at the cincinnati children's hospital medical center (cchmc).

Eligibility criteria:
inclusion criteria: 1. healthy men and women 2. ages between 18 and 45 years 3. bmi between 18 and 29 kg/m2 exclusion criteria: 1. history or clinical evidence of impaired fasting glucose or diabetes mellitus, myocardial infarction within the past year, history or symptoms of congestive heart failure, uncontrolled hypertension, history or active liver or renal disease (ast or alt \>2x upper limits of normal, calculated glomerular filtration rate \[gfr\] \<60). 2. history of pituitary or adrenal disorders or neuroendocrine tumor. 3. anemia defined as hematocrit \<33%. 4. use of medications that alter glucose metabolism 5. pregnancy or lactation. 6. abnormal electrocardiogram (ecg): evidence of ischemia or arrhythmia. 7. women who have a positive pregnancy test at any time during the study period.

Keywords: ghrelin glucose control glp-1 exendin (9-39) insulin
study of lenalidomide (revlimid) in patients with relapsed/refractory peripheral t-cell lymphoma (ptcl) patients

Conditions: Peripheral T-cell Lymphoma

Summary: revlimid is a potent immunomodulatory analogue without the teratogenic effects, which has direct anti-tumor effects, anti-angiogenic and both anti-inflammatory and t-cell costimulatory properties. both preclinical and clinical data indicate its efficacy solid tumor and multiple myeloma including advanced/refractory stages with its role in enhancing host antitumor immunity that provided the rationale to use in patients with ptcl.


Eligibility criteria:
inclusion criteria: * patients with histologic diagnosis of ptcl according to the who-real classification; * age \> 18 years; * relapsed (³1) or refractory to conventional chemotherapy/radiotherapy; * stage i-iv according to the ann arbor staging system; * performance status \<2; * adequate bone marrow reserve: platelets \>50 x 10(9)/l, absolute neutrophil count * (anc) \> 1.0 x 10(9)/l, hemoglobin \>8 g/d; * normal renal and hepatic functions; * negative hiv, hcv, and hbv status; * informed consent prior to registration on study exclusion criteria: * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * pregnant or breast feeding females. (lactating females must agree not to breast feed while taking lenalidomide). * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * use of any other experimental drug or therapy within 28 days of baseline. * known hypersensitivity to thalidomide. * the development of erythema if characterized by a desquamating rash while taking thalidomide or similar drugs. * any prior use of lenalidomide. * concurrent use of other anti-cancer agents or treatments. * known positive for hiv or infectious hepatitis, type a, b or c.

Keywords: ptcl
effect of radiation on tissue for delayed breast reconstruction

Conditions: Breast Cancer

Summary: the purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation.

in the setting of post-mastectomy radiation therapy delayed autologous reconstruction, favored by many attempts to avoid complications encountered with radiating the immediately reconstructed breast. the timing of delayed reconstruction is however not known. the goal of this proposal is to study the gross, structural and vascular changes in radiated mastectomy skin in addition to possible structural and flow changes of the underlying internal mammary vessels over time. we plan to use these objective findings as a basis for determining an ideal time frame for delayed autologous breast reconstruction. sequential mastectomy skin specimens will be obtained from 20 patients undergoing post-mastectomy radiation therapy over a 24 month period and these specimens will be evaluated histologically. these same patients will also undergo serial examinations and photographic documentation of gross skin changes. skin perfusion will be assessed by laser doppler imaging and internal mammary vessel structure, and flow characteristics will be assessed by color doppler sonography. based on these studies, we will elucidate short and long term changes in radiated breast skin, showing inflammatory, structural and perfusion patterns that can be correlated with optimal conditions for reconstruction. this has the potential to dramatically change practice patterns of delayed reconstruction for many reconstructive surgeons and more importantly restore what patients loose with mastectomy in a consistent, timely fashion. there is also potential for improved outcomes of delayed breast reconstruction by decreasing the number of reconstructions performed too soon after completion of radiation.

Eligibility criteria:
inclusion criteria: 1. patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy. 2. patients who meet criteria 1, who plan on postmastectomy breast reconstruction exclusion criteria: 1. male patients 2. patients under the age of 18 3. patients of advanced age (greater than 75) 4. patients with comorbidities that affect wound healing.
a study of experimental medication bms-986036 in adults with nonalcoholic steatohepatitis (nash) and stage 3 liver fibrosis

Conditions: Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis

Summary: this is a study of experimental medication bms-986036 given to adults with nonalcoholic steatohepatitis (nash; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe fibrosis).


Eligibility criteria:
inclusion criteria: * liver biopsy performed within 6 months (26 weeks) prior to the screening period. if historical biopsy is not available, a liver biopsy will be performed during the screening period. biopsy must be consistent with nash, with: a) a score of at least 1 for each nas component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis according to the nash crn classification, as assessed by the central reader * participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period * participants taking vitamin e at doses greater than or equal to (\>=) 800 iu/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the screening period. vitamin e treatment (\>=800 iu/day) must not have been initiated after the qualifying liver biopsy was performed. exclusion criteria: * other causes of liver disease (e.g., alcoholic liver disease, hepatitis b virus infection, chronic hepatitis c virus \[hcv\] infection, autoimmune hepatitis, drug-induced hepatotoxicity, wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with hcv sustained viral response (undetectable hcv rna) for at least 2 years prior to biopsy confirming study eligibility may be eligible * current or past history of hepatocellular carcinoma (hcc) * past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation other protocol defined inclusion/exclusion criteria could apply
evaluate the survival benefits of zemplar versus calcijex in subjects w/ stage v chronic kidney disease on hemodialysis

Conditions: End-Stage Kidney Disease

Summary: to evaluate the survival benefit associated with zemplar therapy as compared to calcijex for the treatment of secondary hyperparathyroidism in subjects with stage v chronic kidney disease on hemodialysis as measured by time to death.


Eligibility criteria:
stage v chronic kidney disease patients on hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin d therapy
study of the effects of xoma 052 on insulin production in subjects with well controlled type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the study hypothesis is that xoma 052 may inhibit beta-cell destruction and enhance beta-cell regeneration. the purpose of this study is to assess the effects of xoma 052 on beta-cell function and insulin production.


Eligibility criteria:
inclusion criteria: * stable type 1 diabetes of \> 2 year duration * no clinically significant change in treatment regimen for t1d * age ≥ 18 years and ≤ 55 years * hba1c \< 7.0% * positive gad65 and/or ia-2 auto-antibodies * peak c-peptide \> 100 pm following iv injection of 1 mg glucagon * body-mass index (bmi) \> 18 and \< 28 kg/m2 * willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study exclusion criteria: * current infection or history of infection * positive for hep b surface antigen (hbsag), hep c virus (hcv), or hiv * history of tuberculosis or positive ppd test * presence of foot, leg, or decubitus ulcers * current immunosuppressive treatment or documented immunodeficiency * history of severe allergic or anaphylactic reactions * history of asthma requiring systemic corticosteroid therapy * coronary intervention (pci, stent placement) or hospitalization for cardiovascular condition within the last 12 months * uncontrolled hypertension * history of congestive heart failure (nyha class iii or iv) * history of a coronary event within the last 12 months * female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding * history of malignancy within the last 5 years * receipt of a live (attenuated) vaccine within the last 3 months other protocol-defined inclusion/exclusion criteria may apply

Keywords: diabetes type 1
frequency of parasite infestation in patients with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria; Parasitic Disease

Summary: the goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the patients, for example eosinophilia.


Eligibility criteria:
inclusion criteria: * diagnosis of a chronic spontaneous urticaria * age: 17 years old and up exclusion criteria: * no diagnosis of a chronic spontaneous urticaria * age: younger than 17 years

Keywords: chronic spontaneous urticaria parasitic disease
parkinson's repository of biosamples and network datasets (tracking parkinson's)

Conditions: Parkinson's Disease

Summary: prospective observational study of parkinson's disease with repeat clinical assessment and biobanking of blood samples.

to identify genetic and biomarker factors which affect the expression of parkinson's disease. primary objective: to define the severity and rates of progression of clinical features of parkinson's disease. secondary objective: to relate clinical phenomenology of parkinson's disease to genetic and biomarker changes.

Eligibility criteria:
a. parkinson's disease patients inclusion criteria 1. diagnosis of parkinson's disease, based on uk brain bank criteria and made within the preceding 3 years ('recent onset cases') or diagnosed at under 50 years ('under 50 years cases') 2. age ≥18 to \<90years 3. subject is able and willing to provided informed consent. exclusion criteria 1. patient has severe comorbid illness that would prevent full study participation 2. patient has features indicating another type of degenerative parkinsonism, e.g. progressive supranuclear palsy 3. drug-induced parkinsonism (drug-unmasked pd is allowed) 4. symmetrical lower body parkinsonism attributable to significant cortical and/or subcortical cerebrovascular disease (patients with 'incidental' small vessel disease on brain imaging are allowed). 5. negative or normal functional imaging of the presynaptic dopamine system 6. the presence of uk brain bank exclusion criteria will be recorded at baseline, allowing for the presence of 1 or 2 exclusion criteria (e.g. dopamine antagonist drug used; more than one affected relative) (if justified e.g. by abnormal spect). b. first degree relatives inclusion criteria 1. age ≥18 to \< 90years 2. resident in the united kingdom and able to access one of the proband study centres. 3. subject is able and willing to provided informed consent. exclusion criteria 1. subject has severe comorbid illness that would prevent study participation 2. subject already has a diagnosis of parkinson's disease
rehabilitation planning consult phase ii trial

Conditions: Head and Neck Neoplasms

Summary: the study will evaluate the efficacy of the rehabilitation planning consult (rpc) to achieve key rehabilitation outcomes in survivors of head and neck cancer compared to a waiting list control group. the rpc is a consultative intervention that teaches survivors to use self-management and problem solving strategies to meet and attain individualized goals. follow-through with plans and goal attainment are facilitated by a rehabilitation consultant. results from this study will be used to plan for a larger multi-site trial and subsequent real world implementation.

survivors of head and neck cancer (hnc) often have significant impairments, functional limitations, and reduced quality of life (ql). rehabilitation services, such as speech-language pathology to improve swallowing, physiotherapy to improve neck mobility, and occupational therapy to enable return to work, can effectively reduce the impact of impairments, restore function, and improve ql. however, access to rehabilitation for survivors of hnc is extremely limited. a trans-professional self-management program is needed to provide resources, links to community providers, and instruction in problem-solving strategies. the program should fit seamlessly into the cancer care system with minimal additional resources. to meet these specifications, an innovative intervention, the rehabilitation planning consult (rpc), was developed and evaluated. the rpc is delivered in 1 to 2 sessions and, in a single arm pilot study, had a moderate to large effect on several aspects of ql and individualized goal attainment. it remains unknown whether the rpc is efficacious in comparison to standard care. in preparation for a phase iii trial, the effect of the rpc, as compared to a standard care control will be estimated, on hnc survivors' ql, attainment of individualized goals, and self-efficacy related to self-management. to facilitate recruitment and ensure ethical provision of services, participants will be randomized to a waiting list control (wlc) or rpc. assessments will be conducted at three time points for the rpc group and four times for the wlc group. based on pilot data, approximately 43% of the rpc group are expected to achieve a minimal important difference (mid) in ql, thus 56 participants per arm, 112 participants total, will be recruited. the primary outcome will be ql related to physical health, measured using the sf-36 physical component summary score (pcs). secondary measures will include individualized goal performance measured using the brief rehabilitation assessment for survivors of hnc, disease-specific ql measured with the fact-hn, and self-efficacy.

Eligibility criteria:
inclusion criteria: * survivor of head and neck cancer * completed treatment in the past 6 months exclusion criteria: * cognitive issues * communication issues * presence of major comorbidities

Keywords: head and neck cancer rehabilitation rehabilitation planning consult self-management
a psycho-educational intervention for symptom cluster management

Conditions: Cancer; Oncology

Summary: the purpose of this study is to develop, implement and undertake a preliminary evaluation of a psychoeducational intervention for managing a cancer-related symptom cluster including pain, fatigue and sleep disturbance experienced by vietnamese cancer patients.


Eligibility criteria:
inclusion criteria: * are diagnosed with any type of cancer * are over 18 years of age * have finished the second chemotherapy cycle * expected prognosis of at least 12 months * karnofsky level of ≥ 60/100. * report three symptoms: fatigue, pain and sleep disturbance at severity level of equal or above 3 during the past 7 days. * ability to communicate in vietnamese exclusion criteria: * inability to complete questionnaires or participate in the intervention due to literacy level or communication impairment. * have been diagnosed with major psychiatric morbidity such as suicidal tendencies or schizophrenia. involved in other clinical trials

Keywords: symptom cluster oncology psychoeducation symptom management fatigue pain sleep disturbance